A trial of BI-1206 for lymphoma and leukaemia

Trial design
This trial was for people with:

• B cell non-Hodgkin lymphoma (NHL) or
• chronic lymphocytic leukaemia (CLL)

The people taking part had already had treatment, but their cancer had come back or continued to get worse.

The research team gave the first few people the lowest dose of BI-1206. They didn’t have any serious side effects. So, the next few people had a higher dose. The team looked at 5 different doses.

The plan was for the first few people to have BI-1206 alone. And for the next few to have BI-1206 with rituximab. But the trial was stopped part way through part A. 

This was because there was another similar trial looking at BI-1206, and they didn’t want to duplicate work. It was not because they were worried about the treatment, or the side effects people were having.

They didn’t continue with the rest of part A or with part B. No one had rituximab as part of this trial.

Results
A total of 14 people joined this trial, 8 men and 6 women. They were between 39 and 78 years old. 

Of these, 12 had CLL and 2 had lymphoma. Most people had the CD32b protein on their cancer cells.

Side effects
Everyone who had treatment had at least 1 side effect. These were often mild or didn’t last long.

Non serious side effects
The most common non serious side effects were:

• 10 people (71%) had a mild allergic reaction called an infusion related reaction
• 8 people (57%) had extreme tiredness (fatigue)
• 4 people (29%) had low levels of blood clotting cells called platelets (thrombocytopenia)
• 2 people (14%) had low levels of red blood cells (anaemia)
• 2 people (14%) had constipation
• 2 people (14%) had diarrhoea
• 2 people (14%) had inflammation of hair follicles (folliculitis)

BI-1206 trial - bar chart showing percentage of people with non serious side effects

Infusion related reactions can happen when you have the treatment, or shortly after. The most common symptoms included an itchy rash, low blood pressure, fast pulse, skin flushing and chills. 

Serious side effects
Researchers can class a side effect as serious for a number of reasons, including if:

• the person has to go to hospital because of it
• it is particularly important for the specific treatment in the trial

In this trial, 8 out of 14 people (57%) had at least one side effect that was classed as serious.

The most common more serious side effects were:

• 6 people (43%) had a more serious allergic reaction (infusion related reaction)
• 1 person (7%) had difficulty breathing and shortness of breath (respiratory failure)
• 1 person (7%) had an infection in their blood (sepsis )

BI-1206 trial - bar chart showing percentage of people with serious side effects

Finding the best dose
Two people had side effects that were serious enough to suggest the dose they were having was too high:

• 1 person had an increase in proteins (enzymes) produced by the liver
• 1 person had a very serious infusion related reaction

Three people decided to stop treatment because of side effects they were having. 

The team were not able to find the best dose of BI-1206 to use because the trial stopped earlier than planned.

How well the treatment worked
It is hard to draw any firm conclusions about how well BI-1206 worked. This is because of the small number of people in the trial.

The team were able to assess this for 10 people who took part. The results showed that the cancer:

• stayed the same for 3 people
• continued to grow for 7 people

They also looked at how people were doing a year after joining the trial. They found that:

• 2 people’s cancer had not got worse
• 7 people were living 

What happened to BI-1206 in the body
The research team took blood samples at regular times. They looked at what happened to the amount of BI-1206 in the blood after different doses.

They also looked at what happened to different blood cells and immune system cells after having BI-1206. 

They found that the doses of BI-1206 that people had didn’t seem to affect many types of white blood cells. But it’s difficult to draw any firm conclusions because of the small number of people in the trial.

Conclusion
The research team concluded that they were not able to find the best dose of BI-1206 to use. 

They found that most people taking part had an infusion related reaction, even with a low dose of BI-1206. And that the doses used in this trial didn’t work very well as a treatment for cancer.

Other trials of BI-1206 in the future may show different results.

Future plans
When this summary was written, BioInvent International AB were planning and running other trials looking at BI-1206. These were for people with lymphoma, leukaemia and solid tumours .

Where this information comes from    
We have based this summary on information from the research team. As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed ) or published in a medical journal yet. The figures we quote above were provided by the research team. We have not analysed the data ourselves.